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Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis (ORALEV)

Primary Purpose

Surgical Wound Infection

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Extra dosage - cefuroxime (750mg) I.V
Colorectal Surgery
Ciprofloxacin 750 mg oral
Metronidazole 250 mg oral
Cefuroxime 1.5 g Intravenous
Metronidazole 1 g Intravenous
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Wound Infection focused on measuring Postoperative Wound Infection, Surgical Wound Infection, Colorectal Surgery Infection Prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients presenting colonic pathology
  • The surgery is not contraindicated
  • Diagnosis of colorectal neoplasia or diverticular disease with surgical indication (stenosis, chronic constipation, recurrent infections etc ..)
  • Indication of segmentary resection or total colectomy
  • Patients who agree to participate voluntarily in the study and signed an informed consent.

Exclusion Criteria:

  • Patients who refuse to participate in the study.
  • Patients undergoing mechanical colon preparation the day before surgery.
  • Patients with rectal cancer
  • Patients with intra-abdominal sepsis before surgery (abscess, diverticulitis).
  • Patients who received preoperative antibiotics for any reason in the two weeks prior to surgery.
  • Patients with inflammatory bowel disease (ulcerative colitis, Crohn's disease and indeterminate colitis)
  • Patients presenting allergy to the drugs under study.
  • Patients that will not strictly follow the assigned prophylaxis regimen
  • Patients undergoing urgent surgery (<24h)

Sites / Locations

  • Hospital de Bellvitge
  • Hospital General Universitario Vall d´Hebron
  • Hospital Universitari de Girona Dr. Josep Trueta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral + Parenteral prophylaxis

Only Parenteral prophylaxis

Arm Description

Outcomes

Primary Outcome Measures

Wound infection
Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently

Secondary Outcome Measures

Hospital stay
Hospital stay since colorectal surgery is done
Direct Adverse Drug Reactions
Allergic reactions Intolerance •This morbidity problems are reported independently as a YES/NO variable
Occlusive problems
Intestinal occlusion, Anastomotic stenosis, Prolonged ileus(>5days),.... Occlusive problems, Iatrogenic problems, Impaired healing ( Anastomotic leak rate , intestinal fistula , vesical fistula, peritonitis...) Bleeding problems, Cardiac complications, Nephro-urinary complications, Respiratory complications, Vascular Complications, Gastrointestinal complications, Neurological complications, Local complications... •This morbidity problems are reported independently as a YES/NO variable
Iatrogenic problems
Damage to structures such as ureters, bowel loops artery / iliac vein .... •This morbidity problems are reported independently as a YES/NO variable
Impaired healing
This is a Clinical measure always supported by image tests. This morbidity problems are reported independently as a YES/NO variable
Bleeding problems
Hemoperitoneum, abdominal hematoma,anastomotic bleeding .... •This morbidity problems are reported independently as a YES/NO variable
Cardiac complications
acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema This is a Clinical measure supported by more specific tests if necessary. This morbidity problems are reported independently as a YES/NO variable Cardiologist report will be required for including this items
Nephro-urinary complications
Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ... This is a Clinical measure supported by more specific tests if necessary. This morbidity problems are reported independently as a YES/NO variable
Respiratory complications
Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ... This is a Clinical measure always supported by image . This morbidity problems are reported independently as a YES/NO variable
Vascular Complications
Deep venous thrombosis, phlebitis, thrombophlebitis, ... This is a Clinical measure supported by more specific test if necessary . This morbidity problems are reported independently as a YES/NO variable
Gastrointestinal complications
Liver failure, gastrointestinal bleeding, severe malnutrition, ... This is a Clinical measure supported by blood test and further test if necessary This morbidity problems are reported independently as a YES/NO variable
Neurological complications
Disorientation, cerebral vascular accident, ... This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable. Neurologist report will be required beyond disorientation.
Local infection
Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary This morbidity problems are reported independently as a YES/NO variable
Local complications
Hematoma, seroma, evisceration This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable

Full Information

First Posted
June 15, 2015
Last Updated
January 12, 2020
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02505581
Brief Title
Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis
Acronym
ORALEV
Official Title
Preoperative Oral Antibiotics and Surgical Site Infections in Colon Surgery Without Mechanical Bowel Preparation. A Prospective, Multicentre, Single Blinded, Randomized Trial (ORALEV Study)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
November 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used. Experimental group: Patients undergoing elective colorectal surgery that involves, colonic resection. The antibiotic prophylaxis in this group will be composed of: An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses) the day before surgery. + Control group: Patients undergoing elective colorectal surgery that involves, colonic resection. The antibiotic prophylaxis in this group will be composed of: An intravenous antibiotic pattern of cefuroxime 1g and metronidazole 1,5gr during anesthetic induction. In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc. There won´t be a placebo treatment. Subject compliance will be evaluated according to the usual practice in surgical care field

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Postoperative Wound Infection, Surgical Wound Infection, Colorectal Surgery Infection Prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
536 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral + Parenteral prophylaxis
Arm Type
Experimental
Arm Title
Only Parenteral prophylaxis
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Extra dosage - cefuroxime (750mg) I.V
Intervention Description
In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc
Intervention Type
Procedure
Intervention Name(s)
Colorectal Surgery
Intervention Description
Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin 750 mg oral
Intervention Description
An oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery.
Intervention Type
Drug
Intervention Name(s)
Metronidazole 250 mg oral
Intervention Description
An oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery.
Intervention Type
Drug
Intervention Name(s)
Cefuroxime 1.5 g Intravenous
Intervention Description
An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction.
Intervention Type
Drug
Intervention Name(s)
Metronidazole 1 g Intravenous
Intervention Description
An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.
Primary Outcome Measure Information:
Title
Wound infection
Description
Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Hospital stay
Description
Hospital stay since colorectal surgery is done
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Direct Adverse Drug Reactions
Description
Allergic reactions Intolerance •This morbidity problems are reported independently as a YES/NO variable
Time Frame
24 hours since the drug is taken
Title
Occlusive problems
Description
Intestinal occlusion, Anastomotic stenosis, Prolonged ileus(>5days),.... Occlusive problems, Iatrogenic problems, Impaired healing ( Anastomotic leak rate , intestinal fistula , vesical fistula, peritonitis...) Bleeding problems, Cardiac complications, Nephro-urinary complications, Respiratory complications, Vascular Complications, Gastrointestinal complications, Neurological complications, Local complications... •This morbidity problems are reported independently as a YES/NO variable
Time Frame
30 days from surgery
Title
Iatrogenic problems
Description
Damage to structures such as ureters, bowel loops artery / iliac vein .... •This morbidity problems are reported independently as a YES/NO variable
Time Frame
30 days after surgery
Title
Impaired healing
Description
This is a Clinical measure always supported by image tests. This morbidity problems are reported independently as a YES/NO variable
Time Frame
30 days after surgery
Title
Bleeding problems
Description
Hemoperitoneum, abdominal hematoma,anastomotic bleeding .... •This morbidity problems are reported independently as a YES/NO variable
Time Frame
30 days after surgery
Title
Cardiac complications
Description
acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema This is a Clinical measure supported by more specific tests if necessary. This morbidity problems are reported independently as a YES/NO variable Cardiologist report will be required for including this items
Time Frame
30 days after surgery
Title
Nephro-urinary complications
Description
Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ... This is a Clinical measure supported by more specific tests if necessary. This morbidity problems are reported independently as a YES/NO variable
Time Frame
30 days after surgery
Title
Respiratory complications
Description
Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ... This is a Clinical measure always supported by image . This morbidity problems are reported independently as a YES/NO variable
Time Frame
30 days after surgery
Title
Vascular Complications
Description
Deep venous thrombosis, phlebitis, thrombophlebitis, ... This is a Clinical measure supported by more specific test if necessary . This morbidity problems are reported independently as a YES/NO variable
Time Frame
30 days after surgery
Title
Gastrointestinal complications
Description
Liver failure, gastrointestinal bleeding, severe malnutrition, ... This is a Clinical measure supported by blood test and further test if necessary This morbidity problems are reported independently as a YES/NO variable
Time Frame
30 days after surgery
Title
Neurological complications
Description
Disorientation, cerebral vascular accident, ... This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable. Neurologist report will be required beyond disorientation.
Time Frame
30 days after surgery
Title
Local infection
Description
Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary This morbidity problems are reported independently as a YES/NO variable
Time Frame
30 days after surgery
Title
Local complications
Description
Hematoma, seroma, evisceration This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients presenting colonic pathology The surgery is not contraindicated Diagnosis of colorectal neoplasia or diverticular disease with surgical indication (stenosis, chronic constipation, recurrent infections etc ..) Indication of segmentary resection or total colectomy Patients who agree to participate voluntarily in the study and signed an informed consent. Exclusion Criteria: Patients who refuse to participate in the study. Patients undergoing mechanical colon preparation the day before surgery. Patients with rectal cancer Patients with intra-abdominal sepsis before surgery (abscess, diverticulitis). Patients who received preoperative antibiotics for any reason in the two weeks prior to surgery. Patients with inflammatory bowel disease (ulcerative colitis, Crohn's disease and indeterminate colitis) Patients presenting allergy to the drugs under study. Patients that will not strictly follow the assigned prophylaxis regimen Patients undergoing urgent surgery (<24h)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eloy Espin Basany, MD PhD
Organizational Affiliation
Hospital Universitari Vall d'Hebron Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
Country
Spain
Facility Name
Hospital General Universitario Vall d´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari de Girona Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32325012
Citation
Espin Basany E, Solis-Pena A, Pellino G, Kreisler E, Fraccalvieri D, Muinelo-Lorenzo M, Maseda-Diaz O, Garcia-Gonzalez JM, Santamaria-Olabarrieta M, Codina-Cazador A, Biondo S. Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):729-738. doi: 10.1016/S2468-1253(20)30075-3. Epub 2020 Apr 21. Erratum In: Lancet Gastroenterol Hepatol. 2020 Apr 30;:
Results Reference
derived

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Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis

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